NCT02674750

Study to Evaluate the Efficacy and Safety of CUDC-907 in Patients With RR DLBCL, Including Patients With MYC Alterations

Open-Label, Phase 2 Study to Evaluate the Efficacy and Safety of CUDC-907 in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma, Including Patients With MYC Alterations

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Curis, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 2, open-label, multicenter trial designed to evaluate the efficacy and safety of CUDC-907 in subjects 18 years and older with Relapsed/Refractory (RR) MYC-altered Diffuse Large B-Cell Lymphoma (DLBCL).

Detailed description

Patients with RR DLBCL will be eligible for treatment with CUDC-907, as long as they have tumor tissue available that can be tested for MYC-altered disease based on one of the following: * Fresh tumor tissue obtained from biopsy accessible lesions , or * Archived tumor tissue (most recent available) Subjects will be required to submit archival tumor samples (most recent available) or fresh tumor samples for central FISH and IHC testing. Subjects whose tumors have been previously characterized as MYC-altered are strongly encouraged to enter the study. For subjects who enter the study with unconfirmed MYC-altered disease, fresh tumor samples are preferred.

Conditions

• Relapsed and/or Refractory Diffuse Large B-cell Lymphoma Including With Myc Alterations

Interventions

Type	Name	Description
DRUG	CUDC-907

Timeline

• Start date: 2016-07-01
• Primary completion: 2019-05-28
• Completion: 2019-05-28
• First posted: 2016-02-04
• Last updated: 2022-04-27
• Results posted: 2022-04-27

Locations

25 sites across 2 countries: United States, Spain